Introduction
Material and methods
Study design and patients
Chemotherapy (physician’s decision; no randomization)
Radiotherapy
Statistical analysis
Results
Feasibility of induction chemotherapy
Randomization
Surgery after completion of study treatment
All patients | % | R0 | % | R1/R2/Rx | % | No surgery | % | p value | |
---|---|---|---|---|---|---|---|---|---|
Number of patients | 180 | 100 | 25 | 13.9 | 11 | 6.1 | 144 | 80 | N/A |
Age at start of study | 66 (41–79) | N/A | 63 (45–73) | N/A | 70 (44–79) | N/A | 66.5 (41–79) | N/A | 0.205 (K-W) |
ECOG at start of study | |||||||||
ECOG 0 | 87 | 48.3 | 14 | 56.0 | 6 | 54.5 | 67 | 46.5 | 0.867 (F) |
ECOG 1 | 78 | 43.3 | 10 | 40.0 | 4 | 36.4 | 64 | 44.5 | |
ECOG 2 | 14 | 7.8 | 1 | 4.0 | 1 | 9.1 | 12 | 8.3 | |
ECOG missing in the database | 1 | 0.6 | 0 | 0 | 0 | 0 | 1 | 0.7 | |
Sex | |||||||||
Male | 114 | 63.3 | 17 | 68.0 | 7 | 63.6 | 90 | 62.5 | 0.909 (F) |
Female | 66 | 36.7 | 8 | 32.0 | 4 | 36.4 | 54 | 37.5 | |
Tumor stage | |||||||||
cT1/cT2 | 9 | 5 | 1 | 4.0 | 1 | 9.1 | 7 | 4.9 | 0.415 (F) |
cT3/cT4 | 134 | 74.4 | 21 | 84.0 | 10 | 90.9 | 103 | 71.5 | |
Not available | 36 | 20 | 3 | 12.0 | 0 | 0 | 33 | 22.9 | |
cT missing in the database | 1 | 0.6 | 0 | 0.0 | 0 | 0 | 1 | 0.7 | |
Nodal status: | |||||||||
cN0 | 50 | 27.8 | 7 | 28.0 | 5 | 45.4 | 38 | 26.4 | 0.412 (F) |
cN+ | 70 | 38.9 | 11 | 44.0 | 4 | 36.4 | 55 | 38.2 | |
Not available | 59 | 32.7 | 7 | 28.0 | 2 | 18.2 | 50 | 34.7 | |
cN missing in the database | 1 | 0.6 | 0 | 0.0 | 0 | 0 | 1 | 0.7 | |
Tumor grading: | |||||||||
G1 | 2 | 1.1 | 0 | 0.0 | 0 | 0 | 2 | 1.4 | 0.875 (F) |
G2 | 69 | 38.3 | 11 | 44.0 | 2 | 18.2 | 56 | 38.9 | |
G3 | 50 | 27.8 | 6 | 24.0 | 4 | 36.4 | 40 | 27.8 | |
Not available | 57 | 31.7 | 7 | 28.0 | 5 | 45.4 | 45 | 31.2 | |
G missing in the database | 2 | 1.1 | 1 | 4.0 | 0 | 0 | 1 | 0.7 | |
Type of surgery: | |||||||||
Pancreatoduodenectomy (Whipple technique) | 13 | 7.2 | 13 | 52.0 | 0 | 0 | – | – | <0.001 (F) |
Distal pancreatectomy | 7 | 3.9 | 5 | 20.0 | 2 | 18.2 | – | – | |
Total pancreatectomy | 6 | 3.3 | 5 | 20.0 | 1 | 9.1 | – | – | |
Core biopsy | 0 | 0 | 0 | 0.0 | 0 | 0 | – | – | |
No resection Surgical exploration only | 7 | 3.9 | 0 | 0.0 | 7 | 63.6 | – | – | |
Type of surgery unknown | 3 | 1.7 | 2 | 8.0 | 1 | 9.1 | – | – | |
No surgery | 141 | 78.3 | 0 | 0.0 | – | – | – | – | |
Consent withdrawn prior to evaluation of resectability at end of study | 3 | 1.7 | – | – | – | – | – | – | |
CA19‑9 prior therapy (U/ml) median (range) | 347.2 (0.60–26,081.00) | 278.9 (0.60–4613.56) | 232.0 (2.0–4743.11) | 421.5 (0.70–26,081.0) | 0.43 (K-W) | ||||
CEA prior therapy (ng/ml) median (range) | 3.45 (0.50–680.00) | 2.9 (0.90–111.10) | 2.90 (0.90–104.0) | 3.6 (0.50–680.0) | 0.216 (K-W) |
Postoperative complications
Survival rate as a function of surgical treatment
R0 resectability assessments before and after neoadjuvant treatment
R0 possible | R0 questionable | R0 impossible | No. of cases | R0 possible x no. of cases | R0 questionable x no. of cases | R0 impossible x no. of cases |
---|---|---|---|---|---|---|
Before: | ||||||
2 | 3 | 0 | 1 | 2 | 3 | 0 |
1 | 3 | 1 | 2 | 2 | 6 | 2 |
1 | 2 | 2 | 1 | 1 | 2 | 2 |
1 | 1 | 3 | 1 | 1 | 1 | 3 |
0 | 3 | 0 | 1 | 0 | 3 | 0 |
0 | 2 | 3 | 1 | 0 | 2 | 3 |
0 | 2 | 2 | 3 | 0 | 6 | 6 |
0 | 2 | 1 | 1 | 0 | 2 | 1 |
0 | 1 | 4 | 1 | 0 | 1 | 4 |
0 | 1 | 3 | 2 | 0 | 2 | 6 |
0 | 0 | 5 | 8 | 0 | 0 | 40 |
0 | 0 | 4 | 3 | 0 | 0 | 12 |
n (∑113) | 6 | 28 | 79 | |||
After: | ||||||
3 | 1 | 0 | 1 | 3 | 1 | 0 |
3 | 0 | 0 | 1 | 3 | 0 | 0 |
2 | 1 | 0 | 2 | 4 | 2 | 0 |
2 | 0 | 0 | 1 | 2 | 0 | 0 |
1 | 2 | 0 | 1 | 1 | 2 | 0 |
1 | 1 | 1 | 2 | 2 | 2 | 2 |
1 | 1 | 0 | 1 | 1 | 1 | 0 |
1 | 0 | 0 | 1 | 1 | 0 | 0 |
0 | 3 | 0 | 1 | 0 | 3 | 0 |
0 | 2 | 1 | 1 | 0 | 2 | 1 |
0 | 2 | 0 | 5 | 0 | 10 | 0 |
0 | 1 | 1 | 3 | 0 | 3 | 3 |
0 | 1 | 0 | 1 | 0 | 1 | 0 |
0 | 0 | 3 | 2 | 0 | 0 | 6 |
0 | 0 | 2 | 1 | 0 | 0 | 2 |
0 | 0 | 0 | 1 | 0 | 0 | 0 |
n (∑58) | 17 | 27 | 14 |